Features

CUSTOMIZABLE

SoftComply Risk Manager Plus is a Risk Analysis add-on for Jira that is fully customizable to any risk management method or approach including Hazard Analysis and FME(C)A. Supports FME(C)A with or without Detectability parameter & RPN (Risk Prioritization Numbers).

TRACEABILITY

SoftComply Risk Manager Plus builds full traceability of risks through links between risks, their mitigation actions, test cases and other related risks for audit trails.

REPORTING

Automated generation of pre-filled and tailorable ISO14971-compliant Risk Reports (Risk Management Plan and Risk Management Report) including the visualization of risks of your choise, i.e. either in Initial and Residual Risk Matrices or in RPN (Risk Prioritization Numbers).

Benefits

SUPPORTS FDA AND CE-MARKING

SoftComply Risk Manager is based on ISO 14971 and IEC 62304 comprehensively focusing on the EU and USA markets .

SAFETY CRITICAL

SoftComply Risk Manager is a must-have Jira add-on for any safety-critical system developer where compliant risk management is a regulatory requirement, e.g. in medical device or automotive industries.

INTEGRATION

SoftComply Risk Manager Plus is fully integrated to Atlassian Jira, with transparent pricing and full support from SoftComply

This website uses cookies to improve your experience. By continuing to use the website, you agree to our use of Cookies. ACCEPT

Privacy & Cookies Policy

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.

Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.

Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.